Quality Assurance Specialist

Quality Assurance Specialist ROCGJP00039432

• Hourly pay: $30-$40/hr
• Worksite: Leading biotechnology company (Philadelphia, PA 19104 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 10 Month Assignment

A leading biotech company is looking for a Quality Assurance Specialist. The candidate will provide quality, technical support, and oversight during manufacturing activities.

Quality Assurance Specialist Responsibilities:

• Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
• Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition
• Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
• Review and evaluate QC testing records and any associated OOS investigations.
• Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
• Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.

Quality Assurance Specialist Qualifications:

• 3-5+ years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
• Bachelor’s Degree in scientific discipline.
• Knowledge of Quality Systems such as Change Control, Investigations and CAPA.
• Ability to communicate effectively with wide range of personnel.
• Technical writing skills related to investigation reports.
• General working knowledge of relevant governmental regulations, cGMP and guidelines.
• With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations.
• Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPA’s, and identifying requirements to implement changes in a controlled GMP environment.

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